Neuroanesthesia & neurocritical care
Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial
Primary result · Catheter occlusionResult — go to the resultHazard ratio 4.4 95% CI 0.6–31.2- terminated early
- Terminated early at interim analysis for increased severe adverse events with intraventricular lavage
Authors' conclusion
This randomized clinical trial of intraventricular lavage vs standard drainage found that intraventricular lavage was encumbered with a significantly increased number of severe adverse events.
Study context
- Population
- Patients with intraventricular hemorrhage (20 [95%] secondary), Denmarkplanned 58
- Participants
- 21 patients
- Comparison
- Intraventricular lavage vs standard drainage
- Intraventricular lavagen = 11
- Standard drainagen = 10reference
- Primary endpoint
- Risk of catheter occlusions
Methodological detailssingle-blinded, investigator-initiated, 1:1 randomisation, 2 centres, prespecified interim analysis
- Single-blinded
- Investigator-initiated
- 1:1 randomisation
- 2 centres
- Prespecified interim analysis
Primary result
Catheter occlusion
Hazard ratio
4.4
95% CI 0.6–31.2
P = 0.14
Events by treatment group
Intraventricular lavage vs Standard drainage
HR 4.4 (95% CI 0.6–31.2); P = 0.14
As reported in the abstract
Further findings
Procedure time for catheter placement
P < 0.001
Safety
| Outcome | Risk difference (95% CI) | P value | |
|---|---|---|---|
| Severe adverse events (main outcome of interim analysis)Standard drainage vs Intraventricular lavage · control vs intervention · interim analysis · prespecified | 0.43 (0.06–0.81) | P = 0.04 | |
| −0.500.51Difference (linear scale) |
| Outcome | IRR (95% CI) | P value | |
|---|---|---|---|
| Severe adverse events (main outcome of interim analysis)Standard drainage vs Intraventricular lavage · control vs intervention · interim analysis · prespecified | 6.0 (1.38–26.1) | P = 0.01 | |
| 0.050.21520Incidence rate ratio (log scale) |
Severe adverse events (main outcome of interim analysis)
- Significantly increased risk of severe AEs with intraventricular lavage; trial terminated early
Original publication
Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial. JAMA Netw Open. Published 2 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →